Product Overview

ViewPoint FUSE Electronic Data Capture Solution

ViewPoint FUSE is the class-leading EDC solution to collect data for all types of clinical trials and registries for all phases of clinical research in both the academic and the community setting. The flexibility of the software allows the solution to work in these various settings, whereas traditional EDC software products are designed solely for clinical research. Furthermore, ViewPoint FUSE’s flexibility is augmented with the easiest-to-use software for the performance of traditional data management, monitoring, and study management activities. From initial site evaluation to the final data export to biostatistics, ViewPoint FUSE offers the most comprehensive, intuitive and flexible EDC solution on the market for complete Electronic Study Management (ESM).

Flexibility Throughout the System

The flexibility in ViewPoint FUSE permeates every aspect of the solution, starting with the Case Report Form (CRF) design to the listings used to find patients. Every user type (Physician, Site Coordinator, Project Manager, Data Manager, Clinical Monitor, Safety Specialist, Medical Liaison or Member of Executive Management) has slightly different needs within the system. To accommodate these various needs, ViewPoint FUSE provides them access to only the data and workflow that they need to perform their tasks. The software branding is completely configurable, which allows the sponsor to extend its corporate or product identity to the users of the system. Branding is not limited to product marketing but can help stamp the identity of a particular sponsor in a given therapeutic area on all areas of the system.

Flexible CRF Design

ViewPoint FUSE provides flexible CRF design. One key focus of traditional paper CRF design has always been to allow for logical data entry into the form. Most existing EDC systems have drastically constrained CRF design by forcing question and answer pairs, organized in a strictly vertical manner. This is particularly unfortunate when, at the same time, these EDC systems require data entry to be performed by site coordinators who have clinical knowledge and particularly appreciate the logical design of a CRF.

ViewPoint FUSE allows for virtually limitless layout flexibility. ViewPoint FUSE further simplifies data entry by providing rich and flexible hide/show and enable/disable logic that can apply to individual fields, groups of fields or entire CRFs. To keep the data clean while doing data entry, the ViewPoint FUSE platform runs all data entry checks (hard, automatic queries, and soft edit checks) upon data entry. This immediate feedback for both univariate and multivariate rules greatly reduces the time to subsequently clean data, which dramatically reduces the time to data lock.

The ViewPoint FUSE Team’s experience with community physicians suggests that most queries can be immediately resolved when the source document is still available. To reduce the number of edit check programming, each data element is type-checked at the point of data entry. Although most EDC systems offer some level of data entry support, ViewPoint FUSE has been designed so that all data rules are expressed as formulas (think of formulas in MS Excel) with a fully configurable message. No additional programming is required, thereby vastly reducing cost and risk of programming errors.

Integrated CRF

Everything comes together on the Integrated CRF screen in ViewPoint FUSE. This one page combines edit checks, queries, questions and data entry fields, and the Reason-for-Change. Queries can be answered immediately while the data is still visible, eliminating the need for navigating through other screens or relying on guesswork to determine the values in question. The Reason-for-Change automatically appears when a value is changed after initial save, again eliminating the need to navigate through multiple screens. In summary, ViewPoint FUSE offers one integrated workflow to provide intuitive data entry, correction and subsequent changes. And all of that is done without the need for one line of additional programming!

Workflow Definition

To help the site know when a patient needs a follow-up visit, a fully extensible visit workflow engine is included within the platform. This engine can deal with treatment arms or algorithms, scheduled visits, unscheduled visits, custom events, randomization, and reminders. Based on the protocol, various components of the workflow engine will be implemented to maximize the efficiency on how the site can enter patient data and be notified of upcoming visits. In addition, the solution can notify the sponsor or CRO if data of particular interest was entered or changed (e.g., specific genetic type, lab test, etc.)

Patient Summary Page

The Patient Summary Screen has been designed to place key administrative tasks needed to run a clinical study onto one dashboard. With one-click action icon functionality, these tasks are not only easily accessible, but are also easy to perform. The key to success starts with leveraging AJAX technology (the same technology used for Google maps) to allow for quick-page load times with the entire patient data entry history, including the certified audit trail, available in seconds without having to navigate to multiple screens.

Primary investigators (PIs) apply their eSignature from the Patient Summary Page with one single click of the mouse. The signature can be configured to apply at the site, patient, visit or CRF level; it can also be required to perform particularly sensitive actions such as data export. The CRF data is immediately accessible to the PI. ViewPoint FUSE offers a unique feature within the data review functionality called “completed but invalid due to value change.” This feature highlights any value change that occurred since the previous review, thereby providing a focus to the data reviewer.

Finally, all data management and monitoring functions are available, including Source Document Verification, Data Management Review, Locking, and Freezing.

Listings

Navigation through patient records is made easy through a variety of listings within the ViewPoint FUSE. These listings are designed to find the records in multiple ways thereby allowing for a variety of navigation options within the system. Standard listings include: Site, Patient, Visit, Form, and Query. These listings, along with sorting and filtering capabilities, allow for easy and efficient navigation through the system.

Central and Branded Homepage

The user homepage is designed to provide a unique dashboard view of the system for each unique user role, making it easy for the users to identify what tasks they need to complete. The homepage shows aggregate counts, study alerts, and action items for the particular user without requiring navigation to the specific CRF, report or listing. The task-oriented interface ensures the user knows immediately what to focus on to complete the objectives of the study. In addition, the study management team is able to communicate to the site users through the Site Message Broadcasting and the Document Management solution. Here, the team can alert sites about issues and post the study documents or newsletters directly in the system for easy access by all users.

Direct Patient Data Entry

ViewPoint FUSE has a user friendly interface where patients can directly enter their Patient Reported Outcomes (PROs) into the system. The homepage paradigm shifts when a patient signs into the system and the task-oriented interface is replaced with guided data entry. Here, the patient views a very simple interface that shows them only the forms that they need to enter. From the Patient homepage, patients launch their questionnaire and are guided through.

EDC Administration

ViewPoint FUSE includes a standard Administrative interface for easy site and user management. This functionality allows authorized users to create and edit user accounts within the system. If the sites were initially identified through the Site/Investigator Evaluation Portal, their contact information is automatically transferred to the EDC system. Otherwise, the ViewPoint FUSE import utility allows for rapid import of contact information for all sites and users. To automate one of the most frequent uses of the EDC Administration function, there is a built-in Forgot Password mechanism which allows users to reset their own password upon correctly answering a set of security questions. This convenient feature eliminates the need to call a helpdesk to reset a password. If requested by the sponsor, the initial temporary password can be sent via email upon answer of a security question.

Compliance

The ViewPoint FUSE Implementation Team’s quality objectives are clearly articulated and formally traced through policies, procedures and related controls. Through our standardization of critical functions, ViewPoint FUSE is able to provide clients appropriate evidence of consistency and quality in both our project and software development lifecycles. Empowering our customers to meet their most exacting clinical, safety, and marketing research objectives is at the core of our business. To this end, our quality assurance includes the evaluation and management of our products and services to ensure compliance with applicable regulatory standards and requirements including, but not limited to FDA’s 21 CFR 11 and relevant Predicate Rules and Guidance documents, ICH, and HIPAA. Administration and reporting of each study.